EEG-based Protocol to Guide Deep Sedation Decreases the Days of Mechanical Ventilation in Patients With SARS-CoV-2 Pneumonia: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Ventilator Free Days
研究概览
简要总结
Deep sedation in patients with COVID-19 may be challenging in many aspects. The use of an EEG-based protocol to guide deep sedation may be useful in this particular population, considering their unusually high sedation requirements.
In the present trial, we aim to evaluate an EEG-based protocol to guide deep sedation in patients with COVID19, using to EEG derived parameters that are displayed in the BIS monitor: Suppression Rate and Spectral Edge Frequency.
The protocol is designed to both minimize the suppression rate along with maintaining a spectral edge frequency over 10 Hz. The use of this protocol may reduce the amount of sedatives administered and, therefore, diminish the time needed for the weaning process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old
- •COVID-19 patient requiring mechanical ventilation
排除标准
- •Contraindication to receive propofol or fentanyl
- •Chronic Liver Disease Child C
- •End-Stage Kidney Chronic Disease
结局指标
主要结局
Ventilator Free Days
时间窗: Day 30
Number of days in which the patient is both alive and out of the invasive mechanical ventilator
次要结局
- Total administered dose of propofol(Day 5)
- Delirium Incidence(Day 30)
- Plasma propofol concentration(Day 5)
- Total administered dose of Fentanyl(Day 5)
- Propofol-Related Infusion Syndrome (PRIS) Incidence(Day 30)
- Accidental extubation(Day 30)
- Hospital length of stay(Day 90)
- Total administered dose of Norepinephrine(Day 5)
- Mortality(Day 30)
- ICU length of stay(Day 30)
- Success of the first weaning trial(Day 30)
研究者
Rodrigo Gutiérrez
Assistant Professor
University of Chile